The Effect of Exercise on Mood After Traumatic Brain Injury

NCT ID: NCT00571545

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2007-10-31

Brief Summary

We proposed to examine the effect of an aerobic exercise intervention on depression in persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury who are assigned to receive the exercise intervention with those in the control group to determine the effect of exercise on levels of depression and specific symptoms related to depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise on activity, participation level, and quality of life will be examined.

HYPOTHESES:

1. Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.

2. Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.

3. Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.

4. Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.

Conditions

Traumatic Brain Injury; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Subjects recruited from the community with a history of traumatic brain injury were enrolled into a 10 week supervised exercise program and encouraged to exercise at home as well.

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: BEHAVIORAL

A supervised aerobic exercise program occurred weekly for 30 minutes with a 15 minute warm-up and a 15 minute cool down. A half hour educational session on aspects of exercise and overcoming barriers to exercise was also instituted.

2

Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period.

Group Type: OTHER

No exercise

Intervention Type: BEHAVIORAL

Controls were wait-listed for the exercise program during the 10 week study period.

Interventions

Aerobic exercise

A supervised aerobic exercise program occurred weekly for 30 minutes with a 15 minute warm-up and a 15 minute cool down. A half hour educational session on aspects of exercise and overcoming barriers to exercise was also instituted.

Intervention Type: BEHAVIORAL

No exercise

Controls were wait-listed for the exercise program during the 10 week study period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Traumatic brain injury 1-5 years prior to enrollment
• Current depression as measured by a score of 5 or greater on the depression portion of the Physician Health Questionnaire (PHQ).
• Sufficient cognitive ability to maintain participation in the study
• Sufficient English language ability to allow participation without an interpreter

Exclusion Criteria

• Current suicidal ideation with intent or plan
• Currently pregnant
• History of significant cardiovascular or respiratory disease
• History of significant cardiovascular or respiratory disease
• Physical barriers to the use of standard aerobic exercise equipment

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Bell

Professor, Department of Rehabilitative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen R Bell, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

Hoffman JM, Bell KR, Powell JM, Behr J, Dunn EC, Dikmen S, Bombardier CH. A randomized controlled trial of exercise to improve mood after traumatic brain injury. PM R. 2010 Oct;2(10):911-9. doi: 10.1016/j.pmrj.2010.06.008.

Reference Type: RESULT

PMID: 20970760 (View on PubMed)

Other Identifiers

H133A020508

Identifier Type: -

Identifier Source: secondary_id

22868-B

Identifier Type: -

Identifier Source: org_study_id